Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Giotto USA, LLC — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K113607 | BIOPSY DIGIT S BIOPSY SL | Giotto USA, LLC | 2012-08-10 | 248 | 0 |
| K111434 | GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L | Giotto USA, LLC | 2011-10-27 | 157 | 0 |
| K062039 | BIOPSY DIGIT-AM | Giotto USA, LLC | 2006-09-11 | 54 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda